Panel Discussion: Striving for Consensus on the Level of Evidence Required for Approval

Time: 11:00 am
day: Day Two Track B AM


  • How can we best reconcile the variance in acceptable measures of ALSFRS-R decline across geographies to get drugs to patients faster?
  • How translatable is success of accelerated approval in familial ALS to sporadic ALS?
  • When are expanded access programs deemed acceptable ahead of final study results?
  • If there’s going to be a move towards accelerated approvals based on surrogate endpoints, what else needs to be done to get full approval?